Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over
Recruiting
Phase 3
Interventional Study
Colonic Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 75 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 774 (estimated)
- Sponsor
- Federation Francophone de Cancerologie Digestive · Other
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About This Trial
Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more. Adjuvant chemotherapy has demonstrated a benefit on disease-free survival and overall survival after a stage III colon cancer resection. Nevertheless adjuvant chemotherapy is poorly used in elderly patients. Prognost…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥ 70 years
* Patient considered able to receive chemotherapy
* Lee score detailed faxed to CRGA
* Stage III colon adenocarcinoma
* R0 resection of the primary tumor
* Start of the potential adjuvant chemotherapy within 12 weeks after surgery
* No prior chemotherapy for col…
Contacts